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Hormone · Profile

Follicle-Stimulating Hormone

FSH · Gonal-F · Follistim · Menopur

Pituitary & Trophic HormonesApproved
MW
980.2g/mol
Formula
C42H65N11O12S2

Follicle-stimulating hormone (FSH) is a glycoprotein hormone produced by the anterior pituitary gland, primarily involved in regulating reproductive processes in both males and females. Researchers primarily study FSH for its critical role in follicle development, ovulation, and its influence on reproductive health. Key findings indicate that FSH not only regulates granulosa cell function to control ovulation but also plays a role in glucose-stimulated insulin secretion in pancreatic islets, suggesting its broader physiological implications. Additionally, emerging studies highlight FSH's involvement in various extragonadal tissues, linking it to conditions such as bone loss and obesity, as well as potential roles in cancer biology. Current research continues to explore these diverse functions of FSH, emphasizing its significance in both reproductive and metabolic health.

Overview

Übersicht

Follicle-stimulating hormone (FSH) is an endogenous glycoprotein hormone produced by the anterior pituitary gland. It plays a crucial role in the regulation of reproductive processes in both males and females. Chemically, FSH is a heterodimer composed of an alpha and a beta subunit, with the beta subunit conferring its specific biological activity. In addition to its natural form, synthetic versions such as Gonal-F and Follistim are used clinically. FSH is primarily involved in the regulation of the reproductive system, including the development of ovarian follicles in females and spermatogenesis in males. Researchers have found that FSH also influences extragonadal tissues, impacting metabolic processes such as glucose-stimulated insulin secretion and potentially contributing to conditions like polycystic ovary syndrome (PCOS) and postmenopausal diabetes. The mechanism of action of FSH involves binding to the follicle-stimulating hormone receptor (FSHR), which activates intracellular signaling pathways such as the cAMP/protein kinase A (PKA) and calcium pathways. This leads to various physiological effects, including the regulation of granulosa cell function and insulin secretion. Pharmacokinetic properties of FSH, particularly its synthetic forms, vary based on the route of administration, but detailed data on half-life and metabolism are limited. Clinically, FSH is used in assisted reproductive technologies and is regulated as a prescription medication in many countries. Researchers have observed its potential implications in cancer biology, though further studies are needed to fully understand its role and therapeutic potential in oncology.

Chemical profile

Chemische Struktur

Chemical structure of Follicle-Stimulating Hormone
FormelC42H65N11O12S2
Molekulargewicht980.2g/mol
CAS-Nummer146479-72-3
PubChem CID62819
Mechanism

Wirkmechanismus

FSH acts on the follicle-stimulating hormone receptor (FSHR), primarily activating the Gαs protein, which stimulates the cAMP/protein kinase A (PKA) and calcium pathways. This cascade promotes processes such as granulosa cell function and glucose-stimulated insulin secretion.

Mechanism

Signalweg

Follicle-stimulating hormone (FSH) exerts its effects primarily through binding to the follicle-stimulating hormone receptor (FSHR), activating the Gαs protein, which subsequently stimulates the cAMP/protein kinase A (PKA) pathway and calcium signaling. This signaling cascade promotes granulosa cell glutamine synthesis, inhibiting apoptosis via the ASK1-JNK apoptotic pathway, and orchestrates glucose-stimulated insulin secretion in pancreatic β-cells. While FSH's role in reproductive physiology is well-established, its mechanisms in extragonadal tissues and other biological processes remain incompletely understood.

Half-Life & Pharmacokinetics

ENEndogenous

Circulating half-life ~3-4 hours

POOral

Poor bioavailability due to first-pass

Pharmacokinetic data for synthetic forms like Gonal-F and Follistim are limited; variations may exist based on formulation.

Storage

Temperature

Refrigerate at 2-8C

Light

Protect from light

Form

Aqueous solution: use within specified period after opening

Notes

Follow specific product guidelines for storage and handling.

Solubility

Löslichkeit

FSH is soluble in water, which is relevant for its formulation as an injectable solution.

Legal Status

🇩🇪DE

Verschreibungspflichtig (prescription only); not listed under BtMG.

🇺🇸US

FDA approved for reproductive use; prescription required.

🇦🇺AU

TGA Schedule 4 (prescription only medicine).

🇬🇧UK

Prescription only medicine (POM); regulated by MHRA.

Legal status information is provided for general reference only and may not reflect the most current regulatory changes. Always verify with official government sources before making any decisions.

Open Questions

Offene Forschungsfragen

Current evidence is limited regarding the precise mechanisms by which FSH influences extragonadal tissues, particularly in relation to metabolic disorders and cancer. Further research is needed to clarify the context-dependent effects of FSH signaling in various tumor types, necessitating larger randomized controlled trials (RCTs) that include diverse populations to assess the implications of FSHR-targeted therapies. Additionally, long-term studies are required to understand the endocrine consequences of manipulating myostatin and FSH levels on fertility and metabolic health.

75 Research Publications

1,998

Total Citations

20

Human/RCT

2.6

Avg. Influence

2025

Latest

Sort
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#01

Recombinant human follicle stimulating hormone (r-hFSH; Gonal-F) versus highly purified urinary FSH (Metrodin HP): results of a randomized comparative study in women undergoing assisted reproductive techniques.

HumanInfluence14.0
199
Researchers observed that recombinant human follicle-stimulating hormone (r-hFSH) is more effective than highly purified urinary FSH in inducing multiple follicular development in women undergoing IVF.
#02

Follicle-stimulating Hormone (FSH) Action on Spermatogenesis: A Focus on Physiological and Therapeutic Roles.

Santi Daniele, et al. · Journal of clinical medicine · 2020

ReviewInfluence1.0
134
The study demonstrated that follicle-stimulating hormone plays a critical role in spermatogenesis and may offer therapeutic benefits for male infertility, although its efficacy varies among individuals.

Key findings

  1. 01FSH is important for the process of sperm production (spermatogenesis).
  2. 02The effectiveness of FSH treatment in men with infertility is not well established.
  3. 03Further research is needed to understand FSH's role and develop new treatment options.
#03

Mapping the follicle-stimulating hormone-induced signaling networks.

ReviewInfluence3.0
119
The review proposed a mapping of follicle-stimulating hormone-induced signaling networks, highlighting the complexity of its biological actions beyond the canonical pathways.
#04

LbetaT2 gonadotroph cells secrete follicle stimulating hormone (FSH) in response to active A.

In VitroInfluence6.0
114
Researchers observed that LbetaT2 gonadotroph cells secrete follicle-stimulating hormone (FSH) in a dose-responsive manner when treated with both GnRH and activin A.
#05

Multiple facets of follicle-stimulating hormone receptor function.

ReviewInfluence8.0
88
Researchers observed that follicle-stimulating hormone receptor activation triggers multiple signaling pathways that regulate reproductive functions in mammals.
#06

Follicle-stimulating hormone and advanced follicle development in the human.

ReviewInfluence2.0
85
The study demonstrated that follicle-stimulating hormone is crucial for late follicular development in humans, with its levels influencing the number of follicles that reach the pre-ovulatory stage.
#07

Extragonadal Effects of Follicle-Stimulating Hormone on Osteoporosis and Cardiovascular Disease in Women during Menopausal Transition.

ReviewInfluence3.0
65
The study demonstrated that elevated follicle-stimulating hormone (FSH) levels may directly influence the risk of osteoporosis and cardiovascular disease in postmenopausal women through extragonadal mechanisms.
#08

Follicle-stimulating hormone treatment in normogonadotropic infertile men.

Review
65
The study demonstrated that follicle-stimulating hormone administration may improve sperm parameters in normogonadotropic infertile men, but efficacy appears to depend on specific patient characteristics.
#09

FSH Beyond Fertility.

Lizneva Daria, et al. · Frontiers in endocrinology · 2019

ReviewInfluence2.0
62
Researchers observed that elevated serum follicle-stimulating hormone may significantly influence bone loss, obesity, cardiovascular risk, and cancer, indicating its biological effects beyond reproduction.

Key findings

  1. 01FSH is important for bone health.
  2. 02FSH may influence cognitive function.
  3. 03FSH has roles beyond reproductive health.
#10

A prospective randomized clinical trial comparing 150 IU and 225 IU of recombinant follicle-stimulating hormone (Gonal-F*) in a fixed-dose regimen for controlled ovarian stimulation in in vitro fertilization treatment.

HumanInfluence4.0
61
The study demonstrated that 225 IU of recombinant follicle-stimulating hormone is more effective than 150 IU in younger women for oocyte retrieval, but does not improve outcomes in older women.

Clinical Trials (25)

Preclinical
Phase I
Phase II
Phase III
Approved

25

Total Trials

4,858

Total Enrolled

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)

NCT00703014COMPLETED
Sponsor

Organon and Co

Enrollment

541

Started

2006

Primary outcome

Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)

PregnancyNeonates

A Prospective, Multi-centric Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α

NCT01111084COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

410

Started

2004

Primary outcome

Follicular development

Ovulation Induction

Efficacy of Pergoveris in Aged IVF Patients

NCT02244866COMPLETED
Sponsor

Vietnam National University

Enrollment

240

Started

2012

Primary outcome

Clinical pregnancy

Infertility

Serum FSH Monitoring for Identification of an Optimal Range During Ovarian Stimulation

NCT06572930RECRUITING
Sponsor

ART Fertility Clinics LLC

Enrollment

150

Started

2024

Primary outcome

Quantitative Measurement of Serum Follicle-Stimulating Hormone (FSH) Levels During Ovarian Stimulation Using Serum Assays.

Ovarian Stimulation

Single Injection of Ganirelix in Gonadotropin Intrauterine Insemination (IUI) Cycles

NCT01286051COMPLETED
Sponsor

Houston Fertility Institute

Enrollment

80

Started

2011

Primary outcome

Pregnancy rates

Compare Pregnancy Rates Between FSH Stimulation and FSH andGnRH Antagonist

AMH and Dosing Regimens for Initial IVF Stimulation Protocols

NCT03098199COMPLETED
Sponsor

Reproductive Specialists of New York

Enrollment

78

Started

2015

Primary outcome

clinical pregnancy rate

Infertility

Is in Vitro Maturation of Oocytes Influenced by the Origin of Gonadotropins Used in Maturation Medium: is There a Difference in Efficiency When Using Urinary Versus Recombinant Produced Follicle Stimulating Hormone and Human Chorionic Gonadotropin

Sponsor

Universitair Ziekenhuis Brussel

Enrollment

35

Started

2022

Primary outcome

oocyte maturation

In Vitro Maturation of Oocytes

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)

NCT00702195COMPLETED
Sponsor

Organon and Co

Enrollment

29

Started

2002

Primary outcome

Pregnancy status at 20 weeks of gestation; Take-home baby rate

Pregnancy

An Observational Study to Compare the Dose of Gonal-fTM FbM Prescribed by the Doctor With the Recommendation of the Dose Calculator Consort and to Evaluate the Ease of Use of Pre-filled Pen of Gonal-fTM FbM Pen

NCT01080729TERMINATED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

25

Started

2009

Primary outcome

Comparison between the initial Gonal-f FbM dose prescribed by the doctor and the initial Gonal-f FbM dose recommended by the CONSORT calculator

Multifollicular Stimulation

Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization

NCT02865681COMPLETED
Sponsor

New Hope Fertility Center

Enrollment

4

Started

2016

Primary outcome

Serum estradiol level

Infertility

Anti-Mullerian Hormone (AMH) Versus Antral Follicle Count (AFC) Guided rFSH Dosing Study

NCT01783301Phase 4COMPLETED
Sponsor

Vietnam National University

Enrollment

348

Started

2011

Primary outcome

Number of oocytes retrieved

Infertility

Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulation in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer (IVF-ET).

NCT06921395Phase 4RECRUITING
Sponsor

LG Chem

Enrollment

248

Started

2025

Primary outcome

Number of oocytes retrieved

Female Infertility

Assessment of Implantation Potential of Embryos by Time-lapse Technology

NCT01760278Phase 4UNKNOWN
Sponsor

Bloom IVF and Fertility Centre

Enrollment

200

Started

2012

Primary outcome

No.of top quality embryos produced in both the arms, study arm and control arm.

Embryo/Fetus DeathBlastocyst DisintegrationAneuploidyComplication of ImplantChemical Pregnancy

Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)

NCT00249834Phase 4COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

166

Started

2004

Primary outcome

Number of Oocytes Retrieved

Infertility

Biosimilar Versus Urinary Gonadotropins

NCT02503605Phase 4UNKNOWN
Sponsor

IVI Madrid

Enrollment

130

Started

2015

Primary outcome

Number of metaphase II oocytes

Infertility

Elonva in Combination With Hp-FSH Versus Elonva With Low Dose hCG

NCT03208972Phase 4COMPLETED
Sponsor

AZ Jan Palfijn Gent

Enrollment

107

Started

2014

Primary outcome

The financial costs of the stimulation in both groups

Infertility

Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI

NCT04727684Phase 4COMPLETED
Sponsor

Damascus University

Enrollment

50

Started

2020

Primary outcome

Prevalence of oocyte dysmorphisms among the studied groups:

In Vitro FertilizationInfertilityIntracytoplasmic Sperm InjectionPolycystic Ovary Syndrome

Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF

NCT01687712Phase 3COMPLETED
Sponsor

Fertility Biotech AG

Enrollment

1,100

Started

2013

Primary outcome

Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population

Infertility

Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

NCT05149924Phase 3COMPLETED
Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

354

Started

2018

Primary outcome

Number of oocytes retrieved

Infertility

Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

NCT01816321Phase 3COMPLETED
Sponsor

Universitair Ziekenhuis Brussel

Enrollment

150

Started

2013

Primary outcome

Ongoing pregnancy

InfertilityPoor Ovarian Response

Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)

NCT01185704Phase 3COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

136

Started

2008

Primary outcome

Estradiol (E2) Levels on r-hCG Day

Polycystic Ovarian Syndrome

A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®

NCT01820728Phase 3COMPLETED
Sponsor

Dong-A ST Co., Ltd.

Enrollment

93

Started

2007

Primary outcome

The ovulation rate after 3 cycles of the injection

InfertilityAnovulation

A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age

NCT01079949Phase 2TERMINATED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

93

Started

2007

Primary outcome

Number of Oocytes Retrieved

InfertilityOvulation Induction

Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women

NCT02592031Phase 1COMPLETED
Sponsor

Merckle GmbH

Enrollment

49

Started

2009

Primary outcome

Comparison of single dose pharmacokinetics (Cmax)

Bioequivalence

Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application

NCT02459418Phase 1COMPLETED
Sponsor

Fertility Biotech AG

Enrollment

42

Started

2015

Primary outcome

Baseline Corrected FSH Area Under the Serum Concentration-time Curve From Zero to the Last Quantifiable Measurement [AUC(0-last)]

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This page is for informational and research purposes only. All information is based on published scientific literature and does not constitute medical advice, diagnosis, or treatment recommendations. Many substances listed may not be approved for human use and may be subject to drug regulation laws (e.g., AMG in Germany, FDA in the US). PepStack does not encourage the use of any substance on humans. Always consult a qualified healthcare professional before making any health-related decisions. Use of this information is entirely at your own risk. PepStack assumes no liability for the accuracy, completeness, or timeliness of the content provided. Full disclaimer